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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K170085
Device Name SONON Ultrasound Imaging System, Model: 300L
Applicant
HEALCERION CO., LTD
804HO, 38-21, DIGITAL-RO 31-GIL,
GURO-GO
seoul,  KR 08376
Applicant Contact jaeyeob jung
Correspondent
THE ALLIS LAW FIRM, PLLC
2437 BAY AREA BLVD., #30
houston,  TX  77058
Correspondent Contact carmelina g. allis
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/10/2017
Decision Date 10/12/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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